| CTRI Number |
CTRI/2022/07/044274 [Registered on: 22/07/2022] Trial Registered Prospectively |
| Last Modified On: |
21/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Pala Madakku Thailam (Internal Medicated Oil) on Osteoporosis |
|
Scientific Title of Study
|
An Open, Non-Randomized, Single Arm, Single Centric Clinical Trial To Evaluate The Effectiveness Of Pala (Citramutti) Madakku Thailam In The Management Of Asthi Vatham (Osteoporosis) Among Out-Patients Attending Ayothidoss Pandithar Hospital, National Institute Of Siddha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Thanigainathan A |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 1, Department of Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9489368257 |
| Fax |
|
| Email |
atn1267@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Lakshmikantham MDS PhD |
| Designation |
Associate Professor & HoD (i/c) |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 1, Department of Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9444466880 |
| Fax |
|
| Email |
drlakshmiramaswamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Thanigainathan A |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Room No 1, Department of Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9489368257 |
| Fax |
|
| Email |
atn1267@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha |
|
|
Primary Sponsor
|
| Name |
National Institute of Siddha |
| Address |
National Institute of Siddha,
Tambaram Sanatorium,
Chennai |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Thanigainathan A |
Ayothidoss Pandithar Hospital |
Room No 1, Department of Maruthuvam,
National Institute of Siddha,
Tambaram Sanatorium
Kancheepuram
TAMIL NADU |
9489368257
atn1267@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, National Institute of Siddha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M818||Other osteoporosis without currentpathological fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Pala (Citramutti) Madakku Thailam (Medicated Oil) |
15 to 30 drops BD Internal with milk for 90 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Bone Mineral Density T-Score less than – 1 will be included. |
|
| ExclusionCriteria |
| Details |
1. K/H/O Renal / Hepatic / cardiac disease
2. K/H/O Prolonged glucocorticoid administration
3. K/H/O Genetic or autoimmune disorders
4. All cases of Secondary Osteoporosis including K/H/O Cushing’s syndrome, K/H/O Hyperparathyroidism. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome of the study will be assessed by using the
1. Bone Mineral Density Scan (Peripheral DXA Scan) T Score before and after treatment.
2. Improvement in Clinical symptoms before and after treatment. |
Screening - 2 months
Enrolment - 2 months
Intervention - 4 months
Data Analysis - 2 months
Follow up - 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction:
This is an open Non Randomised clinical trial that
evaluates therapeutic effectiveness of siddha formulation Pala (Citramutti)
Madakku Thailam in the management of Asthi vatham (Osteoporosis)
patients through improvement of T scores in Bone Mineral Densitometer Scan
before and after treatment. Worldwide,
it is estimated that 1 in 3 women above the age of 50 will experience
osteoporotic fractures, as well as 1 in 5 men. According to the Siddha, Asthivatham (Osteoporosis) can be
treated using the trial drug. The major ingredient Sida cordifolia were
found to be effective in increasing the bone density in patients with osteoporosis in several studies. It also has
rich source of phytoestrogens which inhibit bone resorption and negate the bone
resorption effects. Milk is an excellent calcium source and also suppresses the
bone resorption in Osteoporosis. Sesamum indicum also exhibits pro-osteoblastic
and anti-osteoclastic activity.
Objective: To evaluate the therapeutic effectiveness of Pala
(Citramutti) Madakku Thailam in the management of Asthi
vatham (Osteoporosis) using
T scores of Bone Mineral Densitometer Scan before and after treatment.
Materials and Methods: An Open Non Randomised Clinical Trial with
a total of 10 patients diagnosed of Asthi vatham (Osteoporosis) with age
of above 40 years willing to participate in the study ,by signing the informed
consent form will be enrolled in the study. The trial drug will be given for 90
days along with 1 month follow up.
Result: The average T scores before and after treatment will be statistically
analysed.
Keywords: Pala
Madakku Thailam, Osteoporosis |